EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture (RESTORE)

• ClinicalTrials.gov Identifier: NCT03955458
• Recruitment Status: Withdrawn
• First Posted: May 20, 2019
• Last Update Posted: February 27, 2020
• Sponsor: Pacira Pharmaceuticals, Inc
• Information provided by (Responsible Party): Pacira Pharmaceuticals, Inc

Study Description

Brief Summary:

This study evaluates the effect of EXPAREL on total opioid consumption through 72 hours following fascia iliaca compartment block (FICB) in subjects undergoing repair of intertrochanteric hip fracture.

Condition or disease	Intervention/treatment	Phase
Hip Fractures; Intertrochanteric Fractures	Drug: EXPAREL; Drug: Ropivacaine; Drug: Bupivacaine Hydrochloride	Phase 4

Detailed Description:

The current standard of care treatment for pain relief in patients with intertrochanteric hip fracture is a FICB with continuous infusion of ropivacaine given via catheter.

In this study, some people will receive a single injection FICB with EXPAREL + bupivacaine HCl. The groups will be evaluated to determine the amount of pain medication they took from the FICB to 72 hours after.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase-4, Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Fascia Iliaca Compartment Block Versus Fascia Iliaca Compartment Block With Continuous Infusion of Ropivacaine Per Standard of Care Through a Catheter in Intertrochanteric Hip Fracture Patients
• Actual Study Start Date: August 26, 2019
• Estimated Primary Completion Date: May 2020
• Estimated Study Completion Date: May 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: FICB with EXPAREL; Group 1: Suprainguinal Fascia Iliaca Compartment Block (FICB) with EXPAREL and bupivacaine HCl	Drug: EXPAREL; FICB with EXPAREL + Bupivacaine HCL (single dose); Drug: Bupivacaine Hydrochloride; FICB with EXPAREL + Bupivacaine HCL (Single dose)
Active Comparator: FICB with Standard of Care: ropivacaine; Suprainguinal FICB with continuous infusion of local anesthetic (ropivacaine) via catheter placed in the FIC.	Drug: Ropivacaine; FICB with continuous infusion of ropivacaine

Outcome Measures

Primary Outcome Measures :

1. Primary objective (total opioid consumption in morphine equivalents) [ Time Frame: Through 72 hours post-FICB ]
   to compare total opioid consumption in morphine equivalents following FICB with EXPAREL +bupivacaine HCl to that following continuous infusion of ropivacaine via catheter, from end of FICB placement through 72 hours post-FICB, in subjects undergoing repair of intertrochanteric hip fracture To be measured as date, time, and dosage of all medication administered from the time ICF is signed to 72-hours post-surgery.

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 85 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Individuals between 65 and 85 years of age (inclusive of) at screening.
2. Intertrochanteric femoral fractures with American Society of Anesthesiology physical status 1, 2, or 3.
3. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

1. Hip fracture that requires total arthroplasty.
2. Patients transferred from other hospitals.
3. Patients that have other acute fractures.
4. Pre-existing dementia (Mini-Mental State examination score <20) or delirium (Mini-Mental State examination score <24).
5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, ropivacaine, acetaminophen, NSAIDs).
6. Serious systemic comorbidities that cause a contraindication for EXPAREL/bupivacaine (severe hepatic or renal impairment) or ropivacaine.
7. Use of anticoagulants (including aspirin, except low dose aspirin).
8. Chronic opioid use of ≥ 20 morphine milligram equivalent (MME)/day for more than 7 days in the last 30 days.
9. Body Mass Index (BMI) <17 kg/m2 or >45 kg/m2.
10. Known history of renal or hepatic dysfunction, coagulation or bleeding disorder.
11. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-operative period for pain that is not strictly related to the surgery and which may confound the post-operative assessments based on the physician's discretion.
12. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study.
13. History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
14. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
15. Previous participation in an EXPAREL study.

16. Resident of a skilled nursing facility (SNF), long-term acute care (LTAC) facility, inpatient rehabilitation facility (IRF), or nursing home. Participants from assisted living facilities will be eligible for the study.

    In addition, the subject may be withdrawn from the study if the subject meets the following criteria during the hospital stay:

17. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's post-operative course.
18. Subjects who undergo hip fracture surgery more than 30 hours after admission to the Emergency Department.

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

Investigators

• Study Director: Nayana Nagaraj, MD, PhD, MPH; Pacira BioSciences, Inc.

More Information

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT03955458
• Other Study ID Numbers: 402-C-415
• First Posted: May 20, 2019
• Last Update Posted: February 27, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pacira Pharmaceuticals, Inc:

EXPAREL; FICB; Fascia Iliaca Compartment Block; Ropivacaine

Additional relevant MeSH terms:

Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries; Bupivacaine; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents